NCT06115967

A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of Subcutaneous AZD6912 in Healthy Participants

A Phase I, Randomised, Double-blind, Placebo-controlled, Single Ascending Dose Study of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of Subcutaneous AZD6912 in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of AZD6912 administered subcutaneously (SC) in healthy participants.

Detailed description

In this First-In-Human (FiH) study, eligible participants will be randomly assigned to 6 cohorts in a 3:1 ratio to receive either a single dose of AZD6912 SC or placebo. The first 2 participants in each cohort will be dosed as a sentinel pair, with one receiving AZD6912 SC and the other receiving placebo. The study will comprise of, a screening period of 70 days, a treatment period where participants will stay at the Clinical Unit from the day before study intervention administration until at least 240 hours and will be discharged on Day 11. Outpatient visits would start weekly from Day 15, then bi-weekly from Day 43, 4-weekly from Day 99, and 6-weekly from Day 155, with additional follow-up visits approximately every 4 weeks as needed until complement activity returns to the normal range. The study will last approximately 25 months, including the optional Japanese cohorts, with each participant participating for about 38 weeks or longer until complement activity returns to normal range (per local laboratory).

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	AZD6912	AZD6912 will be administered as a single sub-cutaneous dose.
DRUG	Placebo	Placebo will be administered as a single sub-cutaneous dose.

Timeline

• Start date: 2023-11-15
• Primary completion: 2025-10-16
• Completion: 2025-10-16
• First posted: 2023-11-03
• Last updated: 2025-12-01

Locations

2 sites across 2 countries: Canada, United Kingdom